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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Beads, Hydrophilic, For Wound Exudate Absorption
510(k) Number K870559
Device Name IODOSORB POWDER
Applicant
Perstorp AB C/O Robert Joel Slomoff
9229 Cranford Dr.
Potomac,  MD  20854
Applicant Contact JOEL SLOMOFF
Correspondent
Perstorp AB C/O Robert Joel Slomoff
9229 Cranford Dr.
Potomac,  MD  20854
Correspondent Contact JOEL SLOMOFF
Regulation Number878.4018
Classification Product Code
KOZ  
Date Received02/10/1987
Decision Date 03/20/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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